# K102579: Hyperq AD-100 System

- Pathway: 510(k) (Special)
- Applicant: Biological Signal Processing, Ltd.
- Decided: Dec 2, 2010 after 85 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K082564 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082564: Hyperq System, Biological Signal Processing, Ltd. (2008) Summary page 1.

## Most influential descendants
- K140020: Hyperq Acs-100 System (2014), 0 descendants of its own

## Indications for use
ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in the following cases: * Patients with suspected cardiac abnormalities * Populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics is desired. Stress Testing Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present. Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thus to coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients exercise by bicycle, treadmill, or other means, while the ECG is monitored continuously. Exercise loads are determined by predefined protocols. The ECG signals as well as the HF-QRS signals are recorded for the resting, exercise, and recovery phase portions of the exercise protocol. The changes in both ECG waveforms are compared to the resting ECG records. In the HyperQm stress test, changes in the high frequency of the mid QRS complex, calculated as root-mean-square (RMS) values, are compared to the resting values. ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician. HyperQm The HyperQm Software is intended to be used as an aid to the ECG stress test by means of analysis of high frequency components present within the central portion of the QRS complex. The significance of the HF-QRS changes must be determined by a physician.

Source page: https://510kreport.com/device/K102579
Methodology: https://510kreport.com/methodology